{"id":27805,"date":"2015-03-24T09:08:15","date_gmt":"2015-03-24T09:08:15","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=27805"},"modified":"2015-03-25T08:02:46","modified_gmt":"2015-03-25T08:02:46","slug":"fda-approves-fixed-dose-raltegravir3tc-formulation-merck-holds-back-from-us-marketing","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/27805","title":{"rendered":"FDA approves fixed dose raltegravir\/3TC formulation: Merck holds back from marketing in US"},"content":{"rendered":"

Simon Collins, HIV i-Base<\/strong><\/p>\n

On 6 February 2015, the FDA approved a dual formulation of 300 mg raltegravir with 150 mg lamivudine (3TC).<\/strong> [1]<\/p>\n

The indication is for use in combination with other antiretroviral drugs to treat HIV-1 in adults or children older than six years. Approval was based on pharmacokinetic equivalence in an open-label, single dose, randomised, two-period, crossover study in HIV negative people (n=108).<\/p>\n

The new formulation uses a lower dose of raltegravir that has better bioavailability compared to the current 400 mg twice-daily formulation.<\/p>\n

Raltegravir is an integrase inhibitor and 3TC is an NRTI that is now off-patent.<\/p>\n

The joint formulation is manufactured by Merck and has the brand name Dutrebis.<\/p>\n

Merck does not plan to make this new formulation commercially available immediately post-approval.<\/p>\n

Comment<\/h3>\n

Merck announced submission of this formulation in June 2014.<\/strong> [2]<\/p>\n

Approval in the EU is expected within two months, following a positive recommendation by the Committee for Human Medicinal Products (CHMP) on 22 January 2015. In Europe, a pharmacovigilance plan will be implemented as part of the marketing authorisation.<\/strong> [3]<\/p>\n

Although Merck are not planning to market this in the US, the company are still looking at whether there may be a greater role for the formulation in the UK and Europe.<\/strong><\/p>\n

References:<\/p>\n

    \n
  1. FDA listserve. Dutrebis approved, though not commercially marketed in US at this time. (9 February 2015).
    \nhttp:\/\/content.govdelivery.com\/accounts\/USFDA\/bulletins\/eff796<\/a><\/li>\n
  2. Merck press statement. FDA accepts Merck’s NDA for fixed-dose combination of raltegravir plus lamivudine. (24 June 2014).
    \n    http:\/\/www.mercknewsroom.com\/news-release\/research-and-development-news\/fda-accepts-mercks-nda-fixed-dose-combination-raltegravir<\/a>
    \n    http:\/\/www.mercknewsroom.com\/news-releases<\/a><\/li>\n
  3. Committee for Medicinal Products for Human Use (CHMP) Summary of opinion (initial authorisation): Dutrebis lamivudine\/raltegravir. EMA\/CHMP\/38006\/2015 CHMP. (22 January 2015).
    \n    http:\/\/www.ema.europa.eu\/docs\/en_GB\/document_library\/Summary_of_opinion_-_Initial_authorisation\/human\/003823\/WC500180895.pdf<\/a>\u00a0(PDF)<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    Simon Collins, HIV i-Base On 6 February 2015, the FDA approved a dual formulation of 300 mg raltegravir with 150 mg lamivudine (3TC). [1] The indication is for use in combination with other antiretroviral drugs to treat HIV-1 in adults …<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[3],"tags":[],"class_list":["post-27805","post","type-post","status-publish","format-standard","hentry","category-antiretrovirals"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27805","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=27805"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/27805\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=27805"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=27805"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=27805"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}